Measuring Pelvic Floor Muscle Fitness Before and After Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, Los Angeles
About this trial
This study is being done to better understand and improve treatment for myofascial pelvic pain, a common cause of long-lasting pelvic pain in women. Myofascial pelvic pain is related to tight or dysfunctional pelvic floor muscles and can cause pain as well as bladder, bowel, and sexual problems. Current clinical evaluations mostly rely on physical examination and patient-reported symptoms and do not fully measure how the pelvic floor muscles are functioning.
The purpose of this study is to measure pelvic floor muscle function using a noninvasive imaging method called near-infrared spectroscopy, or NIRS. This method measures changes in muscle blood flow and oxygen levels during muscle contraction and relaxation. The study will examine whether pelvic floor muscle function improves after different treatments and whether these physiologic changes are associated with improvements in pain and symptoms.
The study will enroll 120 adult women who have had pelvic pain for at least three months and have pelvic floor muscle tenderness on examination. Participants will be randomly assigned to one of three groups: education with relaxation exercises, pelvic floor physical therapy focused on myofascial release, or vaginal medication used to help relax pelvic floor muscles.
Participants will take part in four study visits over a six-month period. During these visits, they will complete questionnaires about pain and pelvic symptoms, undergo pelvic floor examinations, and have pelvic floor muscle imaging using the NIRS device while performing brief muscle contractions and relaxations. Some visits will also include collection of blood, urine, and vaginal samples to measure inflammation.
The information gained from this study may help improve the diagnosis and treatment of myofascial pelvic pain by providing objective measures of pelvic floor muscle function and identifying which treatments are most effective for different patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Near Infrared Imaging
Diagnostic testNear-infrared spectroscopy (NIRS) is a noninvasive imaging technique used in this study to assess pelvic floor muscle physiology. The NIRS device uses near-infrared light to measure changes in oxygenated and deoxygenated hemoglobin within the pelvic floor muscles, providing real-time information about muscle blood flow, oxygenation, and recovery during contraction and relaxation. The device is used transvaginally during a standardized protocol that includes brief, guided pelvic floor muscle contractions and relaxations. NIRS measurements are used for assessment purposes only and are not intended for diagnosis or treatment.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: EducationPlacebo comparator 1 intervention
Group B: Pelvic Floor Physical TherapyActive comparator 1 intervention
Group C: Pharmacological ReleaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in pelvic floor muscle oxygenation with treatment
Change from baseline in pelvic floor muscle oxygenation response to standardized contraction, measured using near-infrared spectroscopy (NIRS) after treatment interventions designed to alter pelvic floor muscle fitness
Time frame
Baseline to 3 monthsSecondary outcomes
1
Change in pelvic floor muscle recovery kinetics after pelvic floor therapies
Change from baseline in pelvic floor muscle oxygenation recovery time following contraction, measured using NIRS, with pelvic floor-directed therapies
Time frame
Baseline to 3 months2
Correlation of change in pelvic pain severity with NIRS metrics
Change from baseline in average pelvic pain intensity measured using a numeric rating scale (0-10) as correlated with metrics of pelvic floor muscle oxygenation
Time frame
Baseline to 3 months and 6 months3
Patient Global Impression of Improvement (PGI-I)
Participant-reported overall improvement in pelvic symptoms using the Patient Global Impression of Improvement (PGI-I) scale after pelvic-floor directed therapies. The PGI-I is a single-question, patient-reported scale used to measure perceived treatment response compared to a baseline, which is rated on a seven-point scale from 1 (Very much better) to 7 (Very much worse).
Time frame
3 months and 6 months4
Change in inflammatory biomarkers
Change from baseline in systemic and local inflammatory biomarkers measured from blood, urine, and vaginal samples after pelvic-floor directed therapies. This exploratory aim will examine a wide-range of inflammatory mediators in each biological sample, including: EGF, Eotaxin/CCL11, G-CSF, GM-CSF, IFNα2, IFNγ, IL-1α, IL-1β, IL-1RA, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8/CXCL8, IL-10, IL-12 (p40), IL-12(p70), IL-13, IL-15, IL-17A/CTLA8, IL-17E/IL-25, IL-17F, IL-18, IL-22, IP-10/CXCL10, MCP-1/CCL2, M-CSF, MIG/CXCL9, MIP-1α/CCL3, MIP-1β/CCL4, PDGF-AA, PDGF-AB/BB, RANTES/CCL5, TNFα, TNFβ/LTA, VEGF-A. While the primary analysis will examine IL-6, IL-8, and TNF-β levels before and after treatment (measure in pg/mL), as these have been implicated previously in other myofascial pain conditions, the additional biomarkers may serve to provide additional insight into disease pathophysiology.
Time frame
Baseline to 1-2 weeks after therapyOther outcomes
1
Prediction of treatment response using NIRS metrics
The Near InfraRed Spectroscopic (NIRS) pelvic floor muscle measurements are obtained vaginally during a series of pelvic floor muscle contractions, both short- and long-duration. Features abstracted from the resulting NIRS waveforms \[change in oxygenated hemoglobin (measure in nM) from baseline to during MVC, the sustainable duration of SMVC (sec), and the decrease in the change in oxygenated hemoglobin with MVC over a series of contractions (measured in nM, indicative of muscle fatigue)\] will be combined using generalized linear models to create a single, unitless predictive score that will be correlated with treatment responses. The magnitude of the clinical treatment response will be measured as a decrease in pain scores expressed as a continuous variable using the Numeric Rating Scale (NRS), a validated 11-point, patient-reported tool.
Time frame
Baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov
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